用于药物毒理学评价的器官芯片认证和验证研究进展  

Research progress on qualification and validation of organ-on-chip(s) for drug toxicology evaluation

作　　者：俞月 周晓冰[2] 耿兴超[2] 李波[1,2] YU Yue;ZHOU Xiaobing;GENG Xingchao;LI Bo(Chinese Academy of Medical Sciences,Peking Union Medical College,Beijing 100005,China;Beijing Key Laboratory of Drug Non-clinical Safety Evaluation,National Center for Safety Evaluation of Drugs,National Institutes for Food and Drug Control,Beijing 100176,China)

机构地区：[1]中国医学科学院北京协和医学院,北京100005 [2]中国食品药品检定研究院国家药物安全评价监测中心,药物非临床安全评价研究北京市重点实验室,北京100176

出　　处：《药物评价研究》2023年第1期180-186,共7页Drug Evaluation Research

基　　金：国家“重大新药创制”科技重大专项资助项目(2018ZX09201017-001,2018ZX09101002-002-002)。

摘　　要：随着科学技术的发展,肝脏、肾脏、肺、心脏等单器官芯片模型及多器官芯片模型不断出现,但如何准确评价器官芯片的性能,推动其向药物研发及注册监管的应用仍是当前面临的挑战。为了能够更好地了解器官芯片在药物毒理学研究中应用的法规要求,总结了国际上主要药品监管机构开展的器官芯片认证和验证工作的现状,通过解读国际专家共识并结合目前研究进展,就器官芯片的监管工作提出了几点建议,以期为后续器官芯片在药物安全性评价研究中的应用提供参考。Organ-on-chip(s) models of the liver, kidney, lung, heart and multiple organs have been developed as a result of the scientific technology revolution. To accelerate their application in drug development and medicine registration regulation, especially in toxicological research, guidance is needed in determining how to evaluate their performances precisely. To serve as a reference for subsequent drug safety evaluation, in this article, we first discussed the qualification and validation work of organ-on-chip(s) carried out by several major regulatory agencies in various countries. Then, several reasonable recommendations for organ-on-chip(s)validation by interpreting the expert consensus and the latest research progress were discussed.

关 键 词：器官芯片 药物毒理学 体外新模型 药品监管 药物安全性评价 

分 类 号：R965.3[医药卫生—药理学]